1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10650 1 1: KS P ISO 10650 1:2012 2012 9 14 http:/www.kats.go.krKS P ISO 10650 1:2012 : ( ) ( ) () ( ) : (ISO/TC106) () () ( ) KS P ISO 10650 1:2012 : (http:/www.standard.go.kr) : :2007 10 4 :2012 9 14 2012-0418 : :(ISO/TC106) ( 02-509-7294) (http:/w
2、ww.kats.go.kr). 10 5 , . KS P ISO 10650 1:2012 i ii . iii 1 1 2 1 3 .1 4 1 5 2 5.1 .2 5.2 2 5.3 .3 6 3 7 3 7.1 .3 7.2 4 8 , .14 8.1 14 8.2 15 9 15 A( ) .16 KS P ISO 10650 1:2012 ii . KS P ISO 10650 1: 2007 . KS P ISO 10650 1:2012 iii 2004 1 ISO 106501, DentistryPowered polymerization activators Part
3、s 1: Quartz tungsten halogen lamps . KS P ISO 10650 1:2012 1: Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps 1 . . , , . IEC 60601 1 . 2 . . ( ) . KS C IEC 606011-2, 1-2: : KS P ISO 1942, IEC 606011:1988, Medical electrical equipment Part 1: General requirements fo
4、r safety 3 ISO 1942 IEC 606011, 2. . 3.1 , 4 KS P ISO 10650 1 . a) 1: KS P ISO 10650 1:2012 2 b) 2: 5 5.1 5.1.1 . , . IEC 60601 1, 59. . 5.1.2 . . 5.1.3 . . 5.1.4 IEC 60601 1, 44.7 . 5.1.5 IEC 60601 1, 42. . 5.2 5.2.1 400 nm 515 nm( ) 400 nm 515 nm( ) . 7.2 . 400 nm 515 nm 7.2 . 2 , . 5.2.2 190 nm 3
5、85 nm 190 nm 385 nm 7.2 , 90 % 110 % 2 000 W/m2(200 mW/cm2) . 2 , . 5.2.3 515 nm KS P ISO 10650 1:2012 3 515 nm 7.2 , 90 % 110 % 1 000 W/m2(100 mW/cm2) . 2 , . 5.3 / IEC 60601 1 . a) IEC 60601 1, 7. b) IEC 60601 1, 3.6 52. c) IEC 60601 1, 13. d) IEC 60601 1, 16. e) IEC 60601 1, 44.4 f) IEC 60601 1,
6、58. g) IEC 60601 1, 19. h) IEC 60601 1, 20. i) 60601 1, 49. j) IEC 60601 1, 52. k) IEC 60601 1, 56. l) , IEC 60601 1, 57. m) KS C IEC 60601 1-2 6 ( ) . 7 7.1 7.1.1 A . . . IEC 60601 1, 4.1 4.2 . . 7.1.2 , . a) (232) KS P ISO 10650 1:2012 4 b) (5010) % 7.1.3 IEC 60601 1, 4.6 d) . 7.1.4 , , , IEC 6060
7、1 1, 4.7 . 7.1.5 IEC 60601 1, 4.8 . 7.1.6 (232) 4 . 7.1.7 IEC 60601 1, 4.9 . 7.2 7.2.1 7.2.1.1 7.2.1.1.1 , mm 0.02 mm , 7.2.1.2 7.2.1.2.1 , ( ) 190 nm 1 100 nm ( ) 1). . 2 mm . 7.2.1.2.2 , 2)1) Molectron Power Meter PM 500D-2 Molectron Detector PM-3 Molectron Detector Inc.( , 97224, ) . ISO . . 2) S
8、chott SQ1, Schott GG 385, Schott GG 400 Schott OG 515 . ISO . . KS P ISO 10650 1:2012 5 7.2.1.2.2.1 ( ), (3.00.1) mm , 1 190 nm . 7.2.1.2.2.2 , (3.00.1) mm , 2 385 nm . 7.2.1.2.2.3 , (3.00.1) mm , 3 400 nm . 7.2.1.2.2.4 , (3.00.1) mm , 4 515 nm . X , nm Y , % 1 KS P ISO 10650 1:2012 6 X , nm Y , % T
9、i 2 385 nm X , nm Y , % T Ti 3 400 nm KS P ISO 10650 1:2012 7 X , nm Y , % T Ti 4 515 nm 7.2.1.2.3 , 10 % . 7.2.1.2.4 , 10 % 1 V . 7.2.1.2.5 , 1 7.2.2 7.2.2.1 5 % . . (Z) . 7.2.2.2 7.2.2.2.1 a) 1 : , 90 % 110 % KS P ISO 10650 1:2012 8 b) 2 : . 5 . . 20 . 1 2 3 5 , 7.2.2.2.2 7.2.2.2.2.1 1 4 7.2.2.2.2
10、.2 a) 7.2.2.2.2.2 d) A(7.2.2.2.2.2) 5 7 7.2.2.2.2.3 a) 7.2.2.2.2.3 c) B(7.2.2.2.2.3) . 1 2 3 6 7.2.2.2.2.2 A a) A: . 6 . 1 . KS P ISO 10650 1:2012 9 1 A: nm (%) ( ) 0 . . 20 . A 40 . 1 100 60 2 0 . . 20 . B 40 . 2 90 60 3 0 . . 20 . C 40 . 3 110 60 (A, B, C) 5 1 . 7.2.2.2.2.2 b) 2 b) A: 385 nm 385 n
11、m (Schott GG 385 ) . . 2 . 2 A: 385 nm nm (%) ( ) 0 . . 20 . D 40 . 4 100 60 5 0 . . 20 . E 40 . 5 90 60 6 0 . . 20 . F 40 . 6 385 110 60 (D, E, F) 5 4 . 7.2.2.2.2.2 c) 3 c) A: 400 nm 385 nm 400 nm . KS P ISO 10650 1:2012 10 . 3 . 3 A: 400 nm nm (%) ( ) 0 . . 20 . G 40 . 7 100 60 8 0 . . 20 . H 40 .
12、 8 90 60 9 0 . . 20 . I 40 . 9 400 110 60 (G, H, I) 5 7 . 7.2.2.2.2.2 d) 4 d) A: 515 nm 400 nm 515 nm . . 4 . 4 A: 515 nm nm (%) ( ) 0 . . 20 . J 40 . 10 100 60 11 0 . . 20 . K 40 . 11 90 60 12 0 . . 20 . L 40 . 12 515 110 60 (J, K, L) 5 10 KS P ISO 10650 1:2012 11 7.2.2.2.2.3 B . 6 . 5 . a) B: 100
13、% 100 % . 5 . 5 B: 100 % (%) ( ) 0 . . 20 . A 40 . 40 60 1 60 2 0 . . 20 . D 40 . 40 60 2 385 nm 60 3 0 . . 20 . G 40 . 40 60 3 400 nm 60 4 0 . . 20 . J 40 . 40 60 4 100 515 nm 60 (A, D, G, J) 5 1 . 7.2.2.2.2.3 b) 6 b) B: 90 % 90 % . 6 . KS P ISO 10650 1:2012 12 6 B: 90 % (%) ( ) 0 . . 20 . B 40 . 4
14、0 60 5 60 6 0 . . 20 . E 40 . 40 60 6 385 nm 60 7 0 . . 20 . H 40 . 40 60 7 400 nm 60 8 0 . . 20 . K 40 . 40 60 8 90 515 nm 60 (B E, H, K) 5 5 . 7.2.2.2.2.3 c) 7 c) B: 110 % 110 % . 7 . KS P ISO 10650 1:2012 13 7 B: 110 % (%) ( ) 0 . . 20 . C 40 . 40 60 9 60 10 0 . . 20 . F 40 . 40 60 10 385 nm 60 1
15、1 0 . . 20 . I 40 . 40 60 11 400 nm 60 12 0 . . 20 . L 40 . 40 60 12 110 515 nm 60 (C F, I, L) 5 9 . 7.2.3 7.2.3.1 5 , M , AM LM . , Z 7.2.3.2 7.2.3.4 . 7.2.3.2 a) 190 nm 385 nm ( AM DM ) / Z . b) 400 nm 515 nm( ) ( GM JM ) / Z . c) 515 nm JM / Z . 7.2.3.3 90 % KS P ISO 10650 1:2012 14 a) 190 nm 385
16、 nm ( BM EM ) / Z . b) 400 nm 515 nm( ) ( HM KM ) / Z . c) 515 nm KM / Z . 7.2.3.4 110 % a) 190 nm 385 nm ( CM FM ) / Z . b) 400 nm 515 nm( ) ( IM LM ) / Z . c) 515 nm LM / Z . 7.2.3.5 . 8 nm 100 % 90 % 110 % 190 385 400 515 515 5.2 . 8 , 8.1 IEC 60601 1, 6.8.2 a) d) . , , , . . a) / , b) c) ( , , )
17、 d) e) , , f) g) h) i) j) , , KS P ISO 10650 1:2012 15 k) l) m) , n) o) p) q) 400 nm 515 nm (7.2 ) r) s) t) : “ ” u) : 8.2 IEC 60601 1, 6.8.3 a) c) . 9 . a) b) c) d) e) f) g) KS P ISO 10650 1:2012 16 A ( ) IEC 60601 1, C . . IEC 60601 1, C KS P ISO 10650 1: 2012 C.1 5.1 C.2 5.1 C.3 9. C.4 5.3 a) C.5
18、 4. C.6 / 5.3 c) C.7 5.3 d) C.8 C.9 5.3 f) C.10 C.11 5.1.3 C.12 , , 5.1.1 C.13 5.1.1 C.14 C.15 C.16 5.2 C.17 5.3 m) C.18 C.19 C.20 5.1.5 C.21 5.3 j) C.22 5.2 C.23 , , 5.3 b) C.24 5.3 g) C.25 5.3 h) C.26 7.1.2 C.27 5.3 h) C.28 5.3 e) C.29 ( , ), , , , , 5.1.4 C.30 5.1.1 C.31 C.32 , C.33 C.34 C.35 AP APG C.36 9. 1: 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 10650 1:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS DentistryPowered polymerization activatorsPart 1:Quartz tungsten halogen lamps ICS 1